ABBOTT MEDICAL · Class II · Cleared Dec 17, 2025
| K-number | K252417 |
| Device name | Amplatzer Piccolo Delivery System (9-PDS-04F-045) |
| Applicant | ABBOTT MEDICAL |
| Product code | DQY |
| Device class | Class II |
| Decision date | Dec 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The Amplatzer Piccolo Delivery System is a 4 Fr catheter designed to deliver an Amplatzer Piccolo Occluder through a patient's heart to treat patent ductus arteriosus (PDA). It consists of a delivery catheter, loader, hemostasis valve assembly, and extension tube, enabling physicians to position and deploy the occluder device at the PDA site.
The device incorporates substantially equivalent design, function, packaging, sterilization process, materials, and operating principles as the predicate Amplatzer TorqVue LP Catheter (K162228). Technological differences include different device dimensions, materials, and minor design elements. The delivery catheter is radiopaque for fluoroscopic visibility and features an optimized distal curve for co-axial placement within the PDA.
ISO 11135 (ethylene oxide sterilization to Sterility Assurance Level 10⁻⁶). Biocompatibility testing included cytotoxicity (MEM elution), sensitization (guinea pig maximization), irritation (intracutaneous reactivity), and hemolysis per ISO standards. Non-clinical testing addressed torquability, kink resistance, tensile strength, dimensional accuracy, and simulated use.
The Amplatzer Piccolo Delivery System is substantially equivalent because it shares the same general components, connections, user interface, and principles of operation as the predicate device (K162228). Both devices perform the same intended function—facilitating occluder delivery for PDA treatment—and all biocompatibility and performance testing met established acceptance criteria, demonstrating equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov